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| Dr. Enrique Jacome |
Recent public health efforts have focused extensively on reducing the amount of formula babies are given in the hospital after birth. But in the first randomized trial of its kind, researchers at UC San Francisco have found that giving small amounts of formula in the first few days of life to infants experiencing high levels of early weight loss actually can increase the length of time their mothers end up breastfeeding.
"Until now, we haven't explored if it is possible to identify babies who might benefit from early formula use. This study provides the first evidence that early limited formula (ELF) can provide important benefits to some newborns," said lead author Valerie Flaherman, MD, MPH, an assistant professor of pediatrics and epidemiology and biostatistics at UCSF and a pediatrician at UCSF Benioff Children's Hospital. "Based on our findings, clinicians may wish to consider recommending the temporary use of small amounts of formula to new moms whose babies are experiencing significant early weight loss."
Study findings are published online by the journal Pediatrics, and will appear in an upcoming print issue of the journal.
"Formula use has the potential to be a slippery slope to breastfeeding discontinuation, but ELF is a different way to envision using it," said Flaherman. "Rather than giving full bottles of formula that make it hard for the baby to return to the breast, ELF is a small amount of supplementation with a clear end point that alleviates some of the stress new mothers feel about producing enough milk."
Breastfeeding is known to offer wide-ranging preventive health benefits for babies, reducing their risk for infections and allergies, and providing the perfect balance of nutrients to help infants grow into strong and healthy toddlers. The American Academy of Pediatrics currently recommends that healthy mothers and infants should breastfeed exclusively for the first six months for maximum health benefits.
Women do not immediately produce high volumes of milk after childbirth. Instead, at first mothers secrete small amounts of colostrum, which contains high concentrations of nutrients and antibodies for the baby. During this period, babies often lose weight and new mothers may be concerned that their babies appear fussy or hungry. "Many mothers develop concerns about their milk supply, which is the most common reason they stop breastfeeding in the first three months," said Flaherman.
"But this study suggests that giving those babies a little early formula may ease those concerns and enable them to feel confident continuing to breastfeed," she said.
The study enrolled 40 full-term newborns between 24-48 hours old who had lost more than 5 percent of their birth weight. The babies were randomly assigned either to receive early limited formula (ELF), which consisted of one-third of an ounce of infant formula by syringe following each breastfeeding, or to continue with their intention to breastfeed exclusively. . So as not to interfere with breastfeeding 8 to 12 times a day, the ELF babies were only given small amounts of formula. The syringe was used to avoid the babies developing nipple confusion - when a baby develops a preference for a bottle nipple over the breast. The ELF babies stopped the formula when their mothers began producing mature milk, approximately two to five days after birth.
At the one week assessment, all the babies in both groups were still breastfeeding. However, only 10 percent of the ELF babies had received formula in the last 24 hours, compared with 47 percent of the control group.
After three months, 79 percent of the babies in the study who received early limited formula in the first days of life were still breastfeeding, compared with 42 percent of the babies who did not receive early limited formula. Additionally, 95 percent of the babies who received limited formula in the first few days were breastfeeding to some extent at three months, compared with 68 percent of the babies who did not receive early limited formula.
While impressed with the results of this small study, the authors urged caution in interpreting their results. "It will be important to see whether these results can be confirmed in future, larger studies and in other populations," said senior author Thomas Newman, MD, MPH, a professor of pediatrics and epidemiology and biostatistics at UCSF and a pediatrician at UCSF Benioff Children's Hospital.
The authors stress that the goal of this study is to help babies breastfeed for a longer duration, because breastfeeding is the best method for feeding infants. For some infants with high, early weight loss, this small study is the first to suggest that infant formula used at just the right time, in limited amounts, may help achieve the goal of long-term breastfeeding.
"The results of this study are provocative and challenge conventional wisdom," said James Taylor, MD, medical director for the University of Washington Medical Center's Newborn Nursery, who was unaffiliated with the study. "It is crucial that we have more randomized controlled trials on interventions to increase breastfeeding rather than relying on heavily confounded observational studies or biased expert opinion."
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| Dr. Enrique Jacome |
An ingredient that naturally occurs in breast milk might be used to prevent premature babies from developing a deadly intestinal condition that currently is largely incurable, according to researchers at the University of Pittsburgh School of Medicine and Children's Hospital of Pittsburgh of UPMC in this week's online early edition of theProceedings of the National Academy of Sciences.
The story begins with a baby who is born too early, meaning before 36 weeks gestation, said senior author David Hackam, M.D., Ph.D., Watson Family Professor of Surgery, Pitt School of Medicine, and co-director of the Fetal Diagnosis and Treatment Center at Children's Hospital. Once stable, typically the baby is fed with formula because often breast milk is not readily available to premature infants.
"Within about 10 days of birth, the baby starts to vomit and a few hours later, the belly becomes distended and discolored," Dr. Hackam said. "It becomes clear that the child has developed a major problem in his or her tummy, and an X-Ray will usually confirm the diagnosis of necrotizing enterocolitis, or NEC, in which the intestinal tissue is dying. We have no choice but to remove the dead parts of the intestine, but despite surgery, half of these preemie babies still die from the condition."
Dr. Hackam and his team noted NEC occurs when the intestines start getting colonized with bacteria, a process that occurs normally after birth. They focused on toll-like receptor 4 (TLR4), an immune protein that is involved in recognizing microbes and which they recently discovered plays a role in gut development. In the current work, Hackam and colleagues found that TLR4 is present in higher amounts in the blood vessel lining in preemies than in full-term babies.
The study shows that unlike normal mice, those bred to lack TLR4 in their blood vessels did not develop NEC in a model designed to induce the condition. The findings indicate that bacteria in the blood activate TLR4 leading to a reduction in nitric oxide, which in turn narrows blood vessels and decreases blood flow, Dr. Hackam said.
"This pathway can be dangerous when the preemie's immature gut becomes inflamed from exposure to the bacteria normally present in the intestine," he said. "Abundant TLR4 triggers a shutdown of the blood supply to the intestine, leading to tissue death or necrosis."
Premature babies who are nursed rather than formula-fed are more likely to survive NEC, so co-author and nitric oxide expert Mark Gladwin, M.D., chief, Division of Pulmonary Allergy and Critical Care Medicine, Pitt School of Medicine, and director of Pitt's Vascular Medicine Institute, and the team took a closer look at the components of breast milk.
They found that breast milk contains high levels of sodium nitrate, which is converted to nitrite by gut bacteria. Nitrite can be directly converted to the vasodilator nitric oxide, which can both protect the intestinal lining and improve blood flow.
"The additional nitrite appears to overcome the effects of TLR4 activation and corrects the blood flow problem," Dr. Gladwin said. "When we gave formula supplemented with a sodium nitrate and nitrite analog to the premature mice, we saw improved blood flow in the intestine, and NEC did not develop."
Drs. Hackam and Gladwin are testing the compound, which is FDA approved for other uses, in other models of NEC with the hope that it could be routinely added to formula fed to premature infants to prevent NEC.
"This condition is frightening for parents and frustrating for doctors because currently there is little we can do to treat it," said Dr. Hackam, a pediatric surgeon. "I look forward to one day putting myself out of business and having a therapy that truly saves these children."
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| Dr. Enrique Jacome |
The emergency contraceptive "Plan B One-Step", also known as "the morning after pill", has just been approved by the FDA for use among women and girls at least 15 years old, without the need of a doctor's prescription.
Teva Women's Health, Inc. had previously made an application for Plan B One-Step to be available for sale over the counter, without the need of a prescription, to all women (of any age) last year, but the FDA did not approve it.
Plan B One-Step was approved by the FDA in 2009.
The company then decided to amend their application to make it available over the counter strictly for women 15 years of age and older. This new, amended application, did receive approval.
In order to ensure that the pills aren't sold to any girls younger than 15, the product will include the following labeling "not for sale to those under 15 years of age *proof of age required*, not for sale where age cannot be verified."
Cashiers, pharmacists and shop-assistants will be required to ask for the customer's age.
Plan B One-Step will be widely available as the company says it will distribute the pills to many retail outlets that have an onsite pharmacy, where they expect it to be sold in the family planning area. This way the contraceptive will be available during the retailer's operating hours regardless of whether or not the pharmacy is open.
Plan B One-Step is intended to be used as an emergency contraceptive, only in cases where the primary birth control (such as a condom) appeared not to have been effective. It will be available as a single 1.5 mg tablet to be taken within three days of having unprotected sex.
If a woman is already pregnant and takes Plan B One-Step it will not stop the pregnancy and there is no evidence of it harming a developing fetus.
The FDA Commissioner Margaret A. Hamburg, M.D., said:
"Research has shown that access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States.
The data reviewed by the agency demonstrated that women 15 years of age and older were able to understand how Plan B One-Step works, how to use it properly, and that it does not prevent the transmission of a sexually transmitted disease."
The FDA approved Plan B One-Step without a prescription solely for women 15 years or older because of evidence suggesting that women of that age are likely to understand the product is not intended to be used on a routine basis and that it doesn't protect against sexually transmitted diseases.
It's especially important that women continually check for HIV or AIDS or other sexually-transmitted diseases and seek guidance for the best form of birth control.
The FDA stresses that emergency contraceptives such as Plan B One-Step aren't to be used on a routine basis.
To ensure that the age limitation is adhered to, Teva has said that it's willing to conduct an audit of age verification practices after the product has been approved.
A federal judge, in early April this year ordered the Agency to grant a 2001 citizen's petition that wanted OTC access to PLAN B legalized for women of all ages, and/or make Plan B One-Step available as an OTC medication with no restrictions on either age or point of sale. Teva's application to market PlanB One-Step for females aged 15+ years had been pending before the federal judge's ruling.
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| Dr. Enrique Jacome |
3D mammograms could provide significant improvements in cancer detection and decreasing false positives when used in collaboration regular 2D mammograms, according to a new study by a team of Italian and Australian researchers.
The finding, published in The Lancet Oncology, analyzed whether using 2D and 3D screenings together was more accurate at detecting cancers and decreasing false positives than just 2D screenings.
Led by associate professor Nehmat Houssami, at the University of Sydney's School of Public Health in Australia, the researchers screened 7,292 women with an average age of 58 years in Verona and Trento, Italy. First, their screens were documented using 2D mammograms, and then using a combination of 2D and 3D mammograms.
The investigators found 59 cancers in total in 57 different patients. Approximately two-thirds of the cancers that were found (66%) were detected in both 2D and the combination of 2D and 3D screenings. However, a third (33%) were not seen when only using the 2D - and were only found when using the combination of the 2D and 3D screenings.
These results are the same as a rate of 5.3 cancers per 1000 screens found by 2D alone, and 8.1 cancers found for every 1000 screens by the combination of 2D and 3D screenings.
Earlier studies have looked at the advantages of 3D mammography. However, the current study is the first to draw conclusions about the effectiveness 3D screening in a large sample of women.
Additionally, the researchers found that the combination of 2D and 3D screenings was associated with a decreased number of false positives - when screening finds an unusual abnormality that ends up not being accurate in further testing.
Among all the false positives that happened during the current study, 141 of them happened using 2D screening only, compared with just 73 using the combination of 2D and 3D screenings. Overall, 181 false positives took place at both screen readings - suggesting that this is still a significant problem that needs to be dealt with during breast screening.
According to Professor Houssami:
"Although controversial, mammography screening is the only population-level early detection strategy that has been shown to reduce breast cancer mortality in randomized trials. Irrespective of which side of the mammography screening debate one supports, efforts should be made to investigate methods that enhance the quality of, and hence potential benefit from, mammography screening.
We have shown that integrated 2D and 3D mammography in population breast-cancer screening increases detection of breast cancer and can reduce false-positive recalls depending on the recall strategy. Our results do not warrant an immediate change to breast-screening practice, instead, they show the urgent need for randomised controlled trials of integrated 2D and 3D versus 2D mammography."
Last year, a study published in JAMA suggested that ultrasound screening or MRI in addition to regular mammography screening actually increases breast cancer detection rates among women.
Expenses related to new technologies like 3D mammograms may become a concern. For instance, a study in JAMA Internal Medicine revealed that medicare is putting out as much money screening for breast cancer as it does treating it. Screening expenses for breast cancer in the Medicare program surpassed over $1 billion per year in the fee-for-service program during 2006 to 2007.
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| Dr. Enrique Jacome |
Women who had sufficient amounts ofvitamin D were 32 percent less likely to develop fibroids than women with insufficient vitamin D, according to a study from researchers at the National Institutes of Health.
Fibroids, also known as uterine leiomyomata, are noncancerous tumors of the uterus. Fibroids often result in pain and bleeding in premenopausal women, and are the leading cause of hysterectomy in the United States.
The study of 1,036 women, aged 35-49, living in the Washington, D.C., area from 1996 to 1999, was led by Donna Baird, Ph.D., a researcher at the National Institute of Environmental Health Sciences (NIEHS), part of NIH. Baird and her collaborators at The George Washington University and the Medical University of South Carolina screened participants for fibroids using ultrasound. They used blood samples to measure the primary circulating form of vitamin D, known as 25-hydroxy D. Those with more than 20 nanograms per milliliter of 25-hydroxy D were categorized as sufficient, though some experts think even higher levels may be required for good health. The body can make vitamin D when the skin is exposed to the sun, or vitamin D can come from food and supplements.
Study participants also completed a questionnaire on sun exposure. Those who reported spending more than one hour outside per day also had a decreased risk of fibroids. The estimated reduction was 40 percent. Although fewer black than white participants had sufficient 25-hydroxy D levels, the estimated reduction in prevalence of fibroids was about the same for both ethnic groups.
"It would be wonderful if something as simple and inexpensive as getting some natural sunshine on their skin each day could help women reduce their chance of getting fibroids," said Baird.
Baird also noted that, though the findings are consistent with laboratory studies, more studies in women are needed. Baird is currently conducting a study in Detroit to see if the findings from the Washington, D.C., study can be replicated. Other NIEHS in-house researchers, led by Darlene Dixon, D.V.M., Ph.D., are learning more about fibroid development, by examining tissue samples from study participants who had surgery for fibroids.
"This study adds to a growing body of literature showing the benefits of vitamin D," said Linda Birnbaum, Ph.D., director of NIEHS and the National Toxicology Program.
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| Dr. Enrique Jacome |
Women are more likely to know about intimate beauty treatments than they are about serious health issues that could make them six times more likely to miscarry or give birth prematurely.
Research published this week by Balance Activ reveals that women are much more aware of bikini waxing (67%) and vajazzles (48%) than they are about their own intimate health, with nearly two thirds of all women questioned (61%) unaware or unsure of health problems that could lead to fertility problems, miscarriage and increased risk of STI's.
BV (Bacterial Vaginosis) affects one in three women* and because very few know about it the symptoms are often confused with other infections. It is twice as prevalent as thrush and if left untreated during pregnancy the condition can lead to serious implications:
- Pregnant women with BV are six times more likely to miscarry and twice as likely to give birth prematurely than other women
- It's thought BV is responsible for one in three of all premature births in the UK
- BV can put women at risk of contracting STIs such as Gonorrhoea and Chlamydia
It seems intimate women's health is the last taboo as over a third of women questioned (38%) admit they would only feel comfortable getting health advice from online forums while nearly a fifth (19%) are too embarrassed to speak with a GP.
The research, carried out to coincide with National BV Day (Tuesday 16th April), reveals 63% of women feel angry that more information on intimate health conditions is not made available. Health experts are now calling for more awareness of intimate health and the serious side effects that can be the result of untreated conditions.
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| Dr. Enrique Jacome |
Research led by David H. Martin, MD, Professor and Chief of Infectious Diseases at LSU Health Sciences Center New Orleans, has found that a common sexually transmitted infection-causing parasite "cultivates" bacteria beneficial to it, changing thinking about which comes first - infection or bacteria. The researchers also discovered a previously unknown species of these bacteria.
The research was published ahead of print online in Advance Access in the Journal of Infectious Diseases, and was published online in Research Highlights in Nature Reviews Urology.
Trichomonas vaginalis is a parasite and is a common sexually transmitted infection (STI) in women where it causes vaginal discharge, a higher rate of premature deliveries, and greater susceptibility to infection with the AIDS virus. Many women have this infection and do not know it.
It is known that a change in vaginal bacteria causes a problem known as bacterial vaginosis, and women with this condition are at increased risk of acquiring a trichomonas infection. The researchers wondered if, among women with bacterial vaginosis, there were unique bacterial communities which would make women more susceptible to infection with trichomonas.
"We discovered that there are two unique bacterial communities that are very strongly associated with trichomonas infection," notes Dr. Martin. "In part what is unique about these communities is high concentrations of bacteria known as mycoplasmas. In fact one of these is a completely unknown bacterium which we have named Mnola because it is a mycoplasma discovered in NOLA."
The mycoplasma associated with the other unique bacterial community is Mycoplasma hominis, a well known bacterial pathogen. The data indicate that women with trichomonas and this unique bacterial community suffer from worse disease than the other trichomonas-infected women. They have greater amounts of discharge and redness of the vaginal wall.
"We think that this group might also be at especially high risk for infection with HIV," adds Dr. Martin.
An especially interesting result of this research is that the evidence suggests that the trichomonas parasite is responsible in some way for the appearance these unique mycoplasma dominated bacterial communities.
"So instead of these unique communities predisposing a woman to infection as originally thought, we now believe that trichomonas takes on the role of a farmer in the vaginal environment by cultivating bacterial communities that are in some way beneficial to itself. Proving this hypothesis and figuring out how these bacteria interact with trichomonas will be the subject of future research," concludes Dr. Martin.
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